Specialist, RA Technical CMC
•Master in Sciences or Medical Sciences (Biology, Chemistry, Biochemistry, Medical Sciences, Engineering, Immunology, analytical methods and tools)
•3 years in the pharmaceutical industry or research organization
•Engineer or PhD in Life sciences, Pharmacy or equivalent (Biology, Chemistry, Infectious disease, Biochemistry, Medical Sciences, Engineering, Immunology, analytical methods and tools, Regulatory Affairs, Team and People Management experience)
•Experience in regulatory affairs and/or scientific writing
•Good writing skills, able to negotiate with individuals at same time as understanding departmental constraints/pressure (act with empathy, build network and goodwill) within a highly complex organization (matrix structure, multi-disciplinary and multi-cultural teams)
•Good interpersonal, communication (including presentation) and influencing skills
•Fluent in written and oral English
•Good organizational skills, effective time management, ability to manage multiple tasks
•Good communication skills, from simple communication to negotiation skills , with internal GSK stakeholders (i.e. Management of Production, QC, R&D), but also when required with external non-GSK stakeholders (i.e. regulatory Authorities):
The Specialist, CMC, Global Regulatory Affairs, will be in charge of the writing and edition of technical regulatory documents (CMC documents). These documents are needed to support development and registration of new vaccines, as well as to ensure maintenance of existing vaccine licenses (life-cycle).
The Specialist-CMC, Regulatory Affairs, will ensure adequate interaction/partnership with data generating units within the organization in order to receive documents/information/data suitable for preparation of files in timely manner, in accordance with the applicable regulatory standards and with sound scientific standards– taking into account the evolving regulatory requirements and the needs of the company. The Specialist, CMC, Global Regulatory Affairs role will also be responsible for harmonization of documentation content across regulatory files.
The Specialist-CMC, Regulatory Affairs, will participate and provide input in exchange forum in order to support Projects’ Global Regulatory Lead teams, Regional and Cross-product functional team (e.g. RPTs), represent RA CMC in multidisciplinary teams (e.g. Technical teams), will participate in the definition of regulatory filing strategy and get involved in regulatory authorities’ interactions.
Provide timely quality support to Projects, Regions and Cross-products Function through writing of worldwide technical regulatory documentations:
writing and timely delivery of high quality harmonized/standardized ”Right First Time” technical regulatory documents, as agreed with the business partners (Projects, Regions, & Cross-product function).
Liaising with data generating units within the organization (e.g. GIO, R&D) to ensure adequate receipt of documents in order to write CMC documents of high quality
When applicable, review technical documents prepared by Portfolio/Projects: content and QC check
Internal and external interactions
As applicable, provide adequate input into strategic and scientific expertise to development and life-cycle projects, as appropriate.
In partnership with Portfolio/Projects and Cross-product Function, provide adequate input in strategic and scientific expertise to GSK Vaccine Advisory Bodies, as appropriate
In partnership with Portfolio/Projects, Regional RA teams and Cross-product Function, participate in adequate and efficient interactions with regulatory authorities to optimize scientific RA strategy and content of regulatory documents and files.
Interact appropriately with other RA groups (Facility, Cross-product, Projects, Regions)
Share technical (CMC) regulatory and knowledge based expertise within the CMC teams
Participate in transversal product-related matters, as appropriate
Ensure technical file content is prepared in line with high regulatory and scientific standards, and/or templates
Location: Rockville, Md
You may apply for this position online by selecting the Apply now button.
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